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A systematic methodological review of reported perioperative variables, postoperative outcomes and hernia recurrence from randomised controlled trials of elective ventral hernia repair: clear definitions and standardised datasets are needed

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An Invited commentary to this article was published on 12 February 2018

Abstract

Background

This systematic review assesses the perioperative variables and post-operative outcomes reported by randomised controlled trials (RCTs) of VH repair. This review focuses particularly on definitions of hernia recurrence and techniques used for detection.

Objective

Our aim is to identify and quantify the inconsistencies in perioperative variable and postoperative outcome reporting, so as to justify future development of clear definitions of hernia recurrence and a standardised dataset of such variables.

Methods

The PubMed database was searched for elective VH repair RCTs reported January 1995 to March 2016 inclusive. Three independent reviewers performed article screening, and two reviewers independently extracted data. Hernia recurrence, recurrence rate, timing and definitions of recurrence, and techniques used to detect recurrence were extracted. We also assessed reported post-operative complications, standardised operative outcomes, patient reported outcomes, pre-operative CT scan hernia dimensions, intra-operative variables, patient co-morbidity, and hernia morphology.

Results

31 RCTs (3367 patients) were identified. Only 6 (19.3%) defined hernia recurrence and methods to detect recurrence were inconsistent. Sixty-four different clinical outcomes were reported across the RCTs, with wound infection (30 trials, 96.7%), hernia recurrence (30, 96.7%), seroma (29, 93.5%), length of hospital stay (22, 71%) and haematoma (21, 67.7%) reported most frequently. Fourteen (45%), 11 (35%) and 0 trials reported CT measurements of hernia defect area, width and loss of domain, respectively. No trial graded hernias using generally accepted scales.

Conclusion

VH RCTs report peri- and post-operative variables inconsistently, and with poor definitions. A standardised minimum dataset, including definitions of recurrence, is required.

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Acknowledgements

This work was supported by the United Kingdom National Institute for Health Research (NIHR) via Research for Patient Benefit grant PB-PG-0816-20005 and the University College London Hospitals Biomedical Research Centre (SH). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Funding

Funding has recently been received from the National Institute for Health Research and from Allergan PLC. Neither funders have been involved in the planning, methodology, analysis or write up of the research. National Institute of Health Research, Room 132, Richmond House, 79 Whitehall, London, SW1A 2NS. Allergan Plc, Clonshaugh Business and Technology Park, Coolock, Dublin, D17 E400, Ireland.

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  1. The Abdominal Wall Unit, University College London Hospital, University College London Hospitals NHS Foundation Trust, 235 Euston Road, London, NW1 2BU, UK

    Samuel G. Parker, C. P. J. Wood, R. W. Boulton & A. C. J. Windsor

  2. Upper Gastrointestinal Surgery Department, St Mary’s Hospital, Imperial College Healthcare NHS Trust, Praed Street, London, W2 1NY, UK

    J. W. Butterworth

  3. Centre for Medical Imaging, University College London, 3rd Floor East 250 Euston Road, London, NW1 2PG, UK

    A. A. O. Plumb & S. Halligan

  4. Institute of Applied Health Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

    S. Mallett

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Windsor A.C.J. declares conflicts of interest not directly related to the submitted work; educational grants and speaker for: BARD, LifeCell and Cook. Parker S.G, Wood C.P.J, Butterworth J.W, Boulton R.W, Plumb A.A.O, Mallet S and Halligan S declare no conflict of interest.

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Parker, S.G., Wood, C.P.J., Butterworth, J.W. et al. A systematic methodological review of reported perioperative variables, postoperative outcomes and hernia recurrence from randomised controlled trials of elective ventral hernia repair: clear definitions and standardised datasets are needed. Hernia 22, 215–226 (2018). https://doi.org/10.1007/s10029-017-1718-4

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